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Pharmaceutical form
Clinical particulars
Therapeutic Indications
1
Posology and Method of Administration
Babies and young children may benefit from use of a spacer device with the
Ventolin Inhaler (CFC-Free).
Chronic therapy:-
Adults: Up to 200µg four times daily
Children: Up to 200µg four times daily
On demand use of Ventolin should not exceed four times daily. Reliance on
such supplementary use or a sudden increase in dose indicates deteriorating
asthma (see Special Warnings and Special Precautions for Use).
Contra-indications
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Special Warnings and Special Precautions for Use
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Administration of medicines during pregnancy should only be considered if the
expected benefit to the mother is greater than any possible risk to the foetus.
None reported.
Undesirable Effects
Adverse events are listed below by system organ class and frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100 and
<1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and
very rare (<1/10,000) including isolated reports. Very common and common
events were generally determined from clinical trial data. Rare and very rare
events were generally determined from spontaneous data.
Rare: Hypokalaemia.
Cardiac disorders
Common: Tachycardia.
Uncommon: Palpitations.
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Very rare: Cardiac arrhythmias including atrial fibrillation, supraventricular
tachycardia and extrasystoles.
Vascular disorders
Gastrointestinal disorders
Overdose
The most common signs and symptoms of overdose with salbutamol are
transient beta agonist pharmacologically mediated events (see Special
Warnings and Special Precautions for Use and Undesirable Effects).
Lactic acidosis has been reported in association with high therapeutic doses
as well as overdoses of short-acting beta-agonist therapy, therefore
monitoring for elevated serum lactate and consequent metabolic acidosis
(particularly if there is persistence or worsening of tachypnea despite
resolution of other signs of bronchospasm such as wheezing) may be
indicated in the setting of overdose.
Pharmacological properties
Pharmacodynamic properties
Pharmacokinetic properties
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are a minor route of excretion. The majority of a dose of salbutamol given
intravenously, orally or by inhalation is excreted within 72 hours. Salbutamol is
bound to plasma proteins to the extent of 10%.
After administration by the inhaled route between 10 and 20% of the dose
reaches the lower airways. The remainder is retained in the delivery system or
is deposited in the oropharynx from where it is swallowed. The fraction
deposited in the airways is absorbed into the pulmonary tissues and
circulation but is not metabolised by the lung.
Pharmaceutical particulars
List of excipients
Incompatibilities
None reported.
6
Shelf Life
24 months
The canister should not be broken, punctured or burnt, even when apparently
empty.
Before using for the first time remove the mouthpiece cover by gently
squeezing the sides of the cover, shake the inhaler well, and release two puffs
into the air to make sure that it works. If it has not been used for 5 days or
more, shake it well and release two puffs into the air to make sure that it
works.
2. Check inside and outside of the inhaler including the mouthpiece for
the presence of loose objects.
3. Shake the inhaler well to ensure that any loose objects are removed
and that the contents of the inhaler are evenly mixed.
4. Hold the inhaler upright between fingers and thumb with your thumb on
the base, below the mouthpiece.
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5. Breathe out as far as is comfortable and then place the mouthpiece in
your mouth between your teeth and close your lips around it but do not
bite it.
6. Just after starting to breathe in through your mouth press down on the
top of the inhaler to release salbutamol while still breathing in steadily
and deeply.
7. While holding your breath, take the inhaler from your mouth and take
your finger from the top of the inhaler. Continue holding your breath for
as long as is comfortable.
8. If you are to take further puffs keep the inhaler upright and wait about
half a minute before repeating steps 2 to 6.
9. Replace the mouthpiece cover by firmly pushing and snapping the cap
into position.
IMPORTANT:-
Practise in front of a mirror for the first few times. If you see 'mist' coming from
the top of the inhaler or the sides of your mouth you should start again from
stage 2.
If your doctor has been given you different instructions for using your inhaler,
please follow them carefully. Tell your doctor if you have any difficulties.
1. Remove the metal canister from the plastic casing of the inhaler and
remove the mouthpiece cover.
Medicines classification
8
Name and address
GlaxoSmithKline NZ Limited
Private Bag 106600
Downtown Auckland
NEW ZEALAND
Date of preparation
Version: 3.0